Endovascular aneurysm treatment device and method

ABSTRACT

An self-expanding frame is mounted on the distal end of a shaft. The frame is sized and configured so that it can be inserted into the cavity of an aneurysm. Suction is applied to the interior of the aneurysm through the shaft or through another catheter, and the wall of the aneurysm is collapsed onto the exterior surface of the frame. The frame is then collapsed upon further suction being applied to the interior of the aneurysm, which collapses the aneurysm wall with it. The frame folds down on itself, carrying with it the aneurysm wall. The frame is detachable from the shaft and can be left in the collapsed aneurysm.

[0001] This application is related to and claims priority under 35U.S.C. § 119 to U.S. provisional patent application Ser. No. 60/224,361,filed Aug. 11, 2000, the entire contents of which are incorporated byreference herein.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to systems and processes fortreating an aneurysm, and more particular to an endovascular system andprocess for collapsing an aneurysm.

[0004] 2. Discussion of related art

[0005] Aneurysm treatments have been proposed using a wide variety ofprocesses and devices, which have enjoyed various levels of success andacceptance. Such systems and processes include aneurysm clips,intravascular coils, intravascular injections, detachable intravascularballoons, and the like.

[0006] These prior devices, however, have proven to be difficult toemploy, oftentimes do not lend themselves to deployment in all sizes ofaneurysms, can be imprecise in their deployment, their installation canbe very time consuming, risk rupture of the aneurysm because theyincrease its size, can risk recanalization and/or migration of thedevice in the patient's vasculature, and may not treat the mass effectthat the aneurysm may have caused. Furthermore, the present of adhesionsin the aneurysm makes it difficult to collapse the aneurysm. Theretherefore remains an unmet need in the art for systems and processeswhich do not suffer from one or more of these deficiencies.

SUMMARY OF THE INVENTION

[0007] According to a first aspect of the invention, a method oftreating an aneurysm in a patient comprises the steps of advancing acompressed clip through the distal end of a catheter and into theaneurysm, expanding portions of the clip inside the aneurysm, andfolding a distal segment of the clip on itself together with theadjacent wall of the aneurysm as it becomes dislodged from thestretching bar.

[0008] According to a second aspect of the invention, a system usefulfor treating an aneurysm in a blood vessel of a mammalian patient, theaneurysm having a neck, a wall, and a cavity, comprises an elongatedshaft having a proximal end, a distal end, a longitudinal directiondefined between the proximal end and the distal end, and including atleast one lumen extending therethrough, and a self-expanding framepositioned at the distal end of the shaft, the frame including aplurality of self-expanding sections and at least one joint, each of theplurality of self-expanding sections having an unbiased, expandedcondition and a biased, collapsed condition, each of the plurality ofself-expanding sections being foldable about one of the at least onejoint when in a biased, collapsed condition.

[0009] According to a third aspect of the invention, a catheter usefulfor accessing a vascular location adjacent to an aneurysm, comprises ahollow shaft including a proximal end, a distal end, a longitudinaldirection defined between the proximal end and the distal end, a port ina distal portion of the shaft, and including at least one lumenextending therethrough, and an inflatable member mounted on the shaftadjacent to the shaft distal end, the inflatable member in fluidcommunication with the shaft at least one lumen, the inflatable memberincluding a proximal end, a distal end, and a wall between the proximalend and the distal end which extends to the shaft so that the shaft portis directly exposed to the exterior of the balloon, the wall delimitinga central working channel.

[0010] According to a fourth aspect of the invention, a method oftreating an aneurysm in a patient comprises the steps of advancing acompressed clip through the distal end of a catheter and into theaneurysm, expanding portions of the clip inside the aneurysm, andfolding a distal segment of the clip on itself together with theadjacent wall of the aneurysm as it becomes dislodged from thestretching bar.

[0011] Still other objects, features, and attendant advantages of thepresent invention will become apparent to those skilled in the art froma reading of the following detailed description of embodimentsconstructed in accordance therewith, taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The invention of the present application will now be described inmore detail with reference to preferred embodiments of the apparatus andmethod, given only by way of example, and with reference to theaccompanying drawings, in which:

[0013]FIGS. 1a and 1B illustrates longitudinal and cross-sectional viewsof an exemplary embodiment of an apparatus in accordance with thepresent invention;

[0014]FIG. 2 illustrates the apparatus of FIG. 1 in use according to anexemplary method;

[0015]FIG. 3 illustrates a step later than that illustrated in FIG. 2 inthe exemplary method;

[0016]FIGS. 4a and 4 b illustrate a step later than that illustrated inFIG. 2 in the exemplary method, utilizing two embodiments of apparatusillustrated in FIG. 1;

[0017]FIGS. 5a and 5 b illustrate two embodiments of apparatus inaccordance with the present invention;

[0018]FIGS. 6a-6 c illustrate successive steps of use of an apparatus inaccordance with the present invention;

[0019]FIG. 7 illustrates a vascular aneurysm after collapse thereof inaccordance with the present invention;

[0020]FIG. 8 illustrates a distal end of yet another embodiment of adevice in accordance with the present invention;

[0021]FIG. 9 illustrates a side elevational view of a catheter inaccordance with the present invention;

[0022]FIG. 10 illustrates a top plan view of the catheter of FIG. 9;

[0023] FIGS. 11-17 diagrammically illustrate several steps of treatingan aneurysm in accordance with an aspect of the present invention;

[0024] FIGS. 18-21 diagrammically illustrate several steps of treatingan aneurysm in accordance with another aspect of the present invention;

[0025]FIG. 22 illustrates a distal end of yet another embodiment of adevice in accordance with the present invention; and

[0026] FIGS. 23-28 diagrammically illustrate several steps of treatingan aneurysm in accordance with yet another aspect of the presentinvention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] Apparatus and methods in accordance with the present inventionhave numerous advantages over prior aneurysm clips and methods. Amongthese advantages, immediate closure of an aneurysm can be achieved witha relatively easy-to-use method. The apparatus and methods can be usedto treat all aneurysms regardless of the size or the neck width, and canachieve precise locational deployment and decreased procedure time. Therisk of rupture can be decreased, since the aneurysm volume is neverincreased. Additionally, occlusion of the aneurysm neck can be achievedby a balloon in case rupture does occur. Decreased risk of distalembolization, little or no risk of recanalization or migration,strengthening of the arterial wall at the site of the aneurysm, goodvisualization of the device during and after deployment, and immediateelimination of any mass effect the aneurysm may have caused can also beachieved.

[0028] Referring to the drawing figures, like reference numeralsdesignate identical or corresponding elements throughout the severalfigures.

[0029]FIGS. 1a and 1 b illustrate a first exemplary embodiment of asystem in accordance with the present invention. The system 100 includesa triple lumen catheter 102 having a sidewall 104 and three lumenae 106,108, 110 extending longitudinally therethrough. An inflatable member112, such as a balloon, is positioned adjacent a distal end 114 of thecatheter, and is in fluid communication with one of the three lumenae,e.g., lumen 106. A collapsible element or clip 116 is removably mountedto the distal end of the catheter and is movable between a retracted andcollapsed condition, illustrated in FIG. 1a, and an extended andexpanded condition, illustrated in FIGS. 4a, 4 b, 5 a, and 5 b. In orderto effect collapse and expansion of the clip 116, a longitudinallymovable stretching bar 118 extends proximally from the distal end of thecatheter, and preferably extends both within the clip 116 and the one ofthe catheter lumenae, e.g., lumen 108.

[0030] The system 100 also preferably includes a flexible portion in thedistal end of the catheter 102 so that the catheter can more easilynavigate the sometimes tortuous paths encountered during endovascularprocedures. By way of example and not of limitation, a spring 120 can beincorporated into the distal portions of the catheter 102, preferablyproximal of the balloon 112, to permit the catheter to more easily flexand bend. A pair of steering wires 122 are attached to the catheterdistal to the flexible portion 120 and to a steering mechanism orstation 124 at the proximal end of the catheter. Steering mechanisms forcatheters have previously been proposed in the patent literature, andtherefore a detailed description of station 124 will be omitted herein.

[0031] The catheter 102 also preferably includes at least one, and morepreferably several distal side perfusion holes 126 which are in fluidcommunication with one of the three lumenae, e.g., lumen 110. Thecatheter also includes a one way valve 128 positioned distally of theballoon 112 and also in fluid communication with one of the lumenae.Valve 128 is oriented to permit a vacuum drawn in the catheter tosuction through the valve, for purposes which will be explained ingreater detail below. In accordance with one preferred embodiment, boththe side holes 126 and the valve 128 are in fluid communication with thesame lumen; because the one way valve 128 only permits flow into thecatheter through the valve, perfusion of fluid, e.g. contrast agent,through the side holes 126 will not exit out the catheter through thevalve.

[0032] Turning briefly to FIGS. 5a, 5 b, and 6 a-c, further details ofclips in accordance with the present invention are illustrated. Ingeneral, clips in accordance with the present invention are releasablefrom the catheter or other deployment device inside an aneurysm. Theclips also have a collapsed condition into which the clips are biased bytheir own structures, and an expanded condition into which the clipsmust be moved. FIGS. 5a and 5 b illustrate two different versions of aclip 116 in an expanded condition, with the stretching bar 118 extendingthrough the catheter 102 and through the clip 116. As illustrated inFIGS. 5a and 5 b, the stretching bar 118 also includes a thread, wire,or the like 130 which is connected to the distalmost end of thestretching bar and extends proximally through the catheter 102,preferably within the stretching bar itself.

[0033] The stretching bar 118 includes at least one, and preferablyseveral telescoping sections 132 a-f of decreasing outer diameter. Thus,section f can slide into section e, section e into section d, and soforth, when the wire 130 is pulled proximally. The clip 116 includes atleast one, and preferably several rings 134 a-f which are releasablyheld on the outer surface of the stretching bar 118, e.g., by a frictionfit, a frangible coupling, or the like. To each ring 134 a set of arms136 are attached so that the arms can articulate and fold in toward thestretching bar, in a manner somewhat similar to an umbrella. An outertrellis or covering 138 extends between the opposite ends of the arms.

[0034] In order to deploy the clip 116, the distal end of the catheter102 is positioned in the neck of an aneurysm, as illustrated in FIG. 2.The stretching bar, which is already in its own expanded condition, ispushed distally, carrying with it the collapsed clip 116. As the clipexits the distal end of the catheter, as through a distal port 140,successive sections of the clip expand outward until the clip is fullyexposed and outside of the catheter. The wire 130 is then pulledproximally, causing the sections of the stretching bar to telescope intoone another, with the distalmost section 132 f moving proximally firstinto the next most distal section 132 e. As the distalmost end of thesection 132 f moves into the distalmost end of the section 132 e, thering 134 which was received on the section 132 f is pulled off of thestretching bar, leaving that distalmost section of the clip collapsedproximally against the adjacent section. The wire 130 is pulledproximally until each of the sections 132 has telescoped into theadjacent section, causing a collapsing cascade of the clip sectionsproximally. When the proximalmost section of the stretching bar has beenretracted, the clip is left fully collapsed and separated from thestretching bar and the deployment device, e.g., catheter 102. FIGS. 6a-6c illustrate successive views of this serial collapse of the clip from aside view, while FIG. 7 schematically illustrates the completelycollapsed clip in situ.

[0035] According to additional embodiments, the releasable connectionsbetween the arms 136 and the stretching bar 118 can be formed as twistlocks, meltable connections, for which a resistive heater is positionedat each arm and voltage source is connected thereto, or the like as willbe readily appreciated by one of ordinary skill in the art.

[0036] Turning now to FIG. 8, yet another embodiment of a clip inaccordance with the present invention is illustrated. Clip 200 includesa longitudinally extending hollow, preferably cylindrical shaft 202which extends to a closed, and optionally sealed, distal end 204. Aself-expanding frame 206 is mounted about the distal portions of theshaft 202, and includes a number of segments which can fold about anumber of collapsing joints 208. Preferably, the joints 208 arepositioned in an alternating fashion on different sides of the clip 200,so that the clip can be folded up in an accordion-type manner. When eachof the segments of the frame 206 fold about each joint 208, that segmentfolds onto an adjacent segment, as described in greater detail below.Each joint 208 includes a laterally extending leaf spring which has anunbiased, V-shaped orientation and a biased, flat orientation. Becauseof the presence of the spring in each joint 208, each segment is biasedto fold upon itself, as illustrated in the drawing figures. A stiffeningwire, stretching bar, or mandrel 210 extends through each of thesegments of the frame, and prevents the springs of each of the joints208 from folding each segment upon itself, as described in greaterdetail below.

[0037] The stiffening wire or stretching bar 210 extends longitudinallythrough the shaft 202. The wire or bar 210 allows the practitioner tostraighten or laterally collapse the frame 206; that is, when thebar/wire/mandrel 210 is pushed distally against the distal end 204, theframe 206 can be stretched and collapsed, and proximal retractionremoves this force on the frame and permits the frame to expand.Self-expanding frames are well known to those of skill in the art, suchas those known for use in constructing vascular stents, and thereforethe constructional details of frame 206 are omitted from thisdescription for brevity's sake. As described in greater detail below,the self-expanding frame is constrained from expanding when advancedthrough the vasculature because the frame is carried in a catheter shaftwhich is sized to prevent the frame from expanded until the clip ismoved out of the catheter. Such a practice is also known in the art ofvascular stents, which are typically carried in a collapsed conditioninside a carrier catheter, and thereafter pushed out of the catheterwhich permits them to expand.

[0038] Preferably, at least portions of the shaft 202 are configured sothat upon rotation of the shaft about the longitudinal axis, the shaftis released from the frame 206. By way of example and not of limitation,distal portions of the shaft 202 can include a detent which will passthrough correspondingly sized and shaped holes in the sections of theframe 206 only when the shaft is rotated to align the detent and hole.Other suitable mechanisms will be readily apparent to those of skill inthe art.

[0039]FIGS. 9 and 10 illustrate side elevational and top plan views,respectively, of a catheter 220 which is useful for accessing andpositioning a clip, such as clip 200, in an aneurysm 10. The catheter220 includes a longitudinally extending shaft 222 dimensioned and formedof materials so that it can traverse the vasculature of the patient tobe positioned immediately next to an aneurysm that the practitionerintends to treat. An inflatable balloon 224 is mounted on the distal endof the shaft 222, and includes proximal 226 and distal 228 inflatableportions. A central working channel 228 is formed in the balloon 224 bya portion 246 of the wall of the balloon extending inward to the shaft222. Preferably, at least one, and more preferably several radiopaquemarkers 230 are located around the central working channel 228 so thatit's position in the patient can be monitored fluoroscopically.

[0040] The catheter 220 also preferably includes a mechanism or the likewhich directs a clip radially outward through the working channel 228when the clip is pushed distally through the shaft 222. According to oneexemplary embodiment, this mechanism can be a ramp shaped surface formedin the lumen of the shaft 222, so that when the clip is pushed distallythrough the shaft, the clip's distal motion is converted into radialmotion out of the shaft and into the working channel. According to yetanother exemplary embodiment, a deflectable tube 234 can be mounted onthe shaft at the base of the working channel 228, and a steering thread232 is attached to the tube 234. The steering thread extends proximallythrough the shaft 222 and exits the shaft or is otherwise made availableto the practitioner to manipulate. Upon proximal pulling on the steeringthread 232, the tube 236 can be deflected to point toward the centralworking channel 228, thus directing any clip, such as clip 200, which ispushed through the tube 234 into the working channel.

[0041] Several lumenae extend through the shaft 222. A suction lumen 236extends from a distal port 248, located where the working channel 228meets the shaft 222, to a proximal fitting or suction end 238, andincludes a lock 242. The lock 242 is operable to seal the lumen 236 sothat a relative vacuum can be maintained in the lumen. For example, lock242 can be a stopcock valve. A proximal fitting 244 leads to anotherlumen of the shaft 222, and is the lumen which leads to the deflectabletube 234 and is the lumen in which the clip, e.g., clip 200, islongitudinally advanceable. Thus, the clip 200 can be loaded through thefitting 244 or the tube 234, into the shaft 222 with proximal portionsof the clip extending proximally out of the fitting 244. In thisorientation, the clip is in a collapsed condition because the internaldimensions of the lumen are selected to constrain the clip fromself-expanding. Thereafter, the clip can be advanced distally throughthe tube 234 and laterally into the working channel 228.

[0042] FIGS. 11-17 illustrate several steps in an exemplary method inaccordance with the present invention which utilizes clip 200 andcatheter 220, and are described in more detail below.

[0043] Turning now to FIG. 22, yet another embodiment of a clip inaccordance with the present invention is illustrated. Clip 300 includesa longitudinally extending hollow, preferably cylindrical shaft (notillustrated) which contains a wire/bar/mandrel 308 to move the clip intoan aneurysm. A pair of self-expanding expanding frames 302, 304 aremounted on the end of the clip 300, and include a collapsing joint 306.As in other embodiments herein, radiopaque markers 310 are preferablyprovided on the frames to assist in positioning the clip 300 in theaneurysm neck 12. The joint 306 includes at least one, and preferably aplurality (two are illustrated) leaf springs, as described above. Thesprings are oriented with both ends on one lateral side of the each ofthe frames, i.e., a first V-spring is mounted on the right side of theframes as illustrated in FIG. 22, and a second V-spring is mounted onthe left side of the frames. Thus, when unconstrained by a carryingcatheter, such as catheter 220, the frames tend to open up to theorientation illustrated in FIG. 22.

[0044] Another aspect of the present invention includes methods oftreating an aneurysm. Several embodiments of methods in accordance withthe present invention will now be described with reference to several ofthe drawing figures, and with reference to several of the exemplarydevices described herein. The methods of the present invention are notrestricted to the particular devices described herein, but may beperformed using other devices which are employable into an aneurysmcavity and onto the outer surface of which the aneurysm wall can becollapsed. By way of example and not of limitation, vascular coils, suchas those described in the numerous U.S. patents to Guglielmi et al (see,e.g., U.S. Pat. No. 6,083,220), can be used as a device in the methodsof the present invention.

[0045] A first exemplary embodiment of a method in accordance with thepresent invention, given by way of example and not of limitation,includes, but is not limited to, the steps of:

[0046] 1. Perform a road-mapping arteriogram with measurement of thethree dimensional size of an aneurysm 10 and its neck 12.

[0047] 2. Access the aneurysm neck using a steerable catheter, e.g.catheter 102.

[0048] 3. Lock the distal end of the catheter in a positionperpendicular to the center of the neck transverse axis.

[0049] 4. Slowly inflate a balloon mounted on the distal end of thecatheter with a diluted contrast medium up to the previously measuredsize of the neck. (see FIG. 2)

[0050] 5. Verify complete occlusion of the neck 12 by injection ofcontrast agent through side holes in the catheter positioned justproximal to the balloon, and simultaneously applying suction through aone-way valve at the distal end of the catheter. When no inflow of thecontrast into the catheter is demonstrated together with deformation ofthe aneurysm with the suction, the aneurysm neck is completely closed.

[0051] 6. With the neck completely closed, continue suction to almostcomplete collapse of the aneurysm by creating a vacuum within theaneurysm. (see FIG. 3)

[0052] 7. Obtain transverse and longitudinal measurement of theaneurysm, e.g. using MRI, CT scan, or the like.

[0053] 8. Advance a compressed clip, the size of which has been chosenaccording to the previous measurements, through the distal end of thecatheter. The clip, which is constructed using a principal similar to aself-expanding vascular stent, will start to expand as it is advancedinto the aneurysm. The transverse axis of the clip is preferablymaintained parallel to the longitudinal axis of the artery 14 from whichthe aneurysm 10 is arising. (see FIGS. 4 and 5)

[0054] 9. Maintain the vacuum within the aneurysm with continuoussuction to ensure adherence of the aneurysm wall to the sides of theclip. (FIG. 6a)

[0055] 10. Begin proximal pulling of the wire or thread mounted withinthe stretching bar to telescope the very distal segment into the nextproximal segment. (see FIG. 6b)

[0056] 11. The distal segment of the clip, which folds on itself if notstretched from both ends as described above, will start folding onitself together with the adjacent wall of the aneurysm as it becomesdislodged from the stretching bar. (see FIG. 6c) The aneurysm wall isheld to the outside of the clip by the suction.

[0057] 12. By repeating the process described in steps 10 and 11,successive segments of the stretching bar and clip will continue to foldand complete collapse of the aneurysm will be achieved. (see FIG. 7) Thecatheter can then be withdrawn.

[0058] A second exemplary embodiment of a method in accordance with thepresent invention, given by way of example and not of limitation,includes, but is not limited to, the steps of:

[0059] 1. Perform a road-mapping arteriogram.

[0060] 2. Obtain measurements of the aneurysm, the neck of the aneurysm,and the parent artery.

[0061] 3. Using a transvascular approach, e.g., a right femoralapproach, position the balloon catheter 200 in the parent artery (usingthe guidance of the radiopaque markers on the periphery of the centralworking channel) with the distal segment of the balloon distal, e.g.,immediately distal, of the aneurysm neck, and the proximal segmentproximal, e.g., immediately proximal, to the aneurysm neck (see FIGS.9-11)

[0062] 4. Slowly inflate the balloon to achieve occlusion of the parentartery both proximal and distal to the neck.

[0063] 5. Pull the steering thread within the catheter shaft to directthe steerable section of the catheter to a position as close and asperpendicular as possible to the neck (see FIG. 12).

[0064] 6. Apply a moderate amount of suction using a suitable device,e.g., a syringe attached to a lock mounted on the proximal end of thecatheter to decompress the aneurysm; activate the lock to maintain therelative vacuum in the aneurysm (see FIG. 10).

[0065] 7. Stiffen the distal segment of the aneurysm clip with thestiffening wire by pulling on the proximal segment of the wire and thenpush it until it reaches the sealed top of the clip.

[0066] 8. Push both the stiffening wire and the clip into the aneurysmcavity, firmly holding both of these elements together; theself-expanding frame of the clip will start to expand as the clip isdeployed (see FIG. 13).

[0067] 9. Apply strong suction through the catheter to collapse theaneurysm wall completely around the expanded clip (see FIG. 14).

[0068] 10. Turn off the vacuum lock at the proximal end of the catheterwhile applying strong vacuum to the catheter lumen to ensure that avacuum is maintained within the aneurysm to assist, and preferablyensure, that the aneurysm wall adheres to the outside of the clip.

[0069] 11. Start pulling the stiffening wire through the sealed proximalend of the catheter to release the most distal segment of the clip,which will fold onto itself about the joint because of the action of thesprings in the joints, together with the adjacent aneurysm wall which isheld by the vacuum (see FIGS. 15, 16), which may be at least in partassisted by the force of the vacuum pushing inward on the frames of theclip.

[0070] 12. Repeat steps 10 and 11 so that successive segments orsections of the clip continue to fold and at least partial, andpreferably complete, collapse of the aneurysm will be achieved (see FIG.17).

[0071] 13. Rotate the shaft, e.g., counterclockwise, to dislodge theshaft from the collapsed segment(s) of the clip.

[0072] A third exemplary embodiment of a method in accordance with thepresent invention, given by way of example and not of limitation,includes, but is not limited to, the steps of the above described secondembodiment, with the following modification. The clip is positioned atthe neck of the aneurysm and the very proximal end of the aneurysmsegment. Only the portion of the clip that is in the aneurysm is folded,leaving the rest of the aneurysm decompressed but not fully collapsedonto the outer surface of the clip (see FIGS. 18-21). This and otheraspects of the invention can be particular useful in the treatment ofaneurysms which include adhesions, which make complete collapse of theaneurysm wall difficult because they make the wall less pliable.

[0073] A fourth exemplary embodiment of a method in accordance with thepresent invention, given by way of example and not of limitation,includes, but is not limited to, utilizing the clip 300 (see FIG. 22) inthe following manner and including the steps of:

[0074] 1. Perform steps 1-6 as described in the second embodiment above.

[0075] 2. Introduce the distal segment of the clip to a point justdistal of the neck of the aneurysm, i.e., just inside the aneurysmcavity (see FIG. 25).

[0076] 3. Apply strong suction and lock it in to maintain vacuum in theaneurysm cavity.

[0077] 4. Pull the distal segment of the clip to push (fold) down theaneurysm neck (see FIG. 26).

[0078] 5. Introduce the proximal segment of the clip into the parentartery, e.g., through a catheter 220, just proximal of the neck andpermit or cause the joint of the proximal segment to collapse (see FIG.27).

[0079] 6. Dislodge the pushing wire by turning it, e.g., in acounterclockwise direction (see FIG. 28).

[0080] As will be readily appreciated by one of skill in the, thepresent invention also extends to the combination of a deploymentcatheter, such as catheter 220, with any of the embodiments of theaneurysm clips described herein to access and treat an aneurysm.

[0081] While the invention has been described in detail with referenceto preferred embodiments thereof, it will be apparent to one skilled inthe art that various changes can be made, and equivalents employed,without departing from the scope of the invention. Each of theaforementioned published documents is incorporated by reference hereinin its entirety.

What is claimed is:
 1. A system useful for treating an aneurysm in ablood vessel of a mammalian patient, the aneurysm having a neck, a wall,and a cavity, comprising: an elongated catheter having a proximal end, adistal end, and including at least one lumen extending therethrough; atelescoping stretching rod positioned in the catheter; at least onesteering pull wire extending distally through the catheter and attachedadjacent to the distal end of the catheter; an inflatable memberpositioned adjacent the catheter distal end; a one-way valve positionedadjacent the catheter distal end and in fluid communication with the atleast one lumen, the one-way valve oriented to permit fluid flow intothe catheter lumen; an expandable clip releasably attached to thecatheter distal end, the expandable clip having an unbiased, expandedcondition and a biased, collapsed condition; wherein when the expandableclip is positioned inside the cavity of an aneurysm and expands, whenthe inflatable member is inflated to substantially seal the neck of theaneurysm from the blood vessel, and when suction is applied through thecatheter lumen and through the one-way valve, the aneurysm wall at leastpartially collapses on the expanded clip.
 2. A system in accordance withclaim 1, further comprising: a flexible spring positioned adjacent thecatheter distal end, the spring including a distal end, at least onesteering pull wire attached to the catheter adjacent to the springdistal end.
 3. A system useful for treating an aneurysm in a bloodvessel of a mammalian patient, the aneurysm having a neck, a wall, and acavity, comprising: an elongated shaft having a proximal end, a distalend, a longitudinal direction defined between the proximal end and thedistal end, and including at least one lumen extending therethrough; aself-expanding frame positioned at the distal end of the shaft, theframe including a plurality of self-expanding sections and at least onejoint, each of the plurality of self-expanding sections having anunbiased, expanded condition and a biased, collapsed condition, each ofthe plurality of self-expanding sections being foldable about one of theat least one joint when in a biased, collapsed condition.
 4. A system inaccordance with claim 3, wherein the frame includes a closed distal end,and further comprising: a stiffening rod extending through the shaftlumen, the stiffening rod being longitudinally movable in the lumen. 5.A system in accordance with claim 3, wherein the frame sections aredetachable from the elongated shaft.
 6. A system in accordance withclaim 3, wherein the frame sections are radially collapsible.
 7. Asystem in accordance with claim 3, further comprising: a stiffening rodextending through the shaft lumen, the stiffening rod beinglongitudinally movable in the lumen.
 8. A catheter useful for accessinga vascular location adjacent to an aneurysm, comprising: a hollow shaftincluding a proximal end, a distal end, a longitudinal direction definedbetween the proximal end and the distal end, a port in a distal portionof the shaft, and including at least one lumen extending therethrough;an inflatable member mounted on the shaft adjacent to the shaft distalend, the inflatable member in fluid communication with the shaft atleast one lumen, the inflatable member including a proximal end, adistal end, and a wall between the proximal end and the distal end whichextends to the shaft so that the shaft port is directly exposed to theexterior of the balloon, the wall delimiting a central working channel.9. A catheter in accordance with claim 8, further comprising: alongitudinally movable steering wire extending along the shaft; and adeflectable tube mounted at the shaft port, the steering wire attachedto the deflectable tube so that when the steering wire is pulledproximally, the deflectable tube deflects laterally.
 10. A catheter inaccordance with claim 8, further comprising: a suction port on a distalportion of the shaft directly exposed to the exterior of the balloon;and a suction lumen extending through the shaft from the shaft proximalend to the suction port.
 11. A catheter in accordance with claim 8,further comprising: at least one radiopaque marker mounted immediatelyadjacent to the central working channel.
 12. A method of treating ananeurysm in a patient comprising the steps of: advancing a compressedclip through the distal end of a catheter and into the aneurysm;expanding portions of the clip inside the aneurysm; folding a distalsegment of the clip on itself together with the adjacent wall of theaneurysm as it becomes dislodged from the stretching bar.
 13. A methodin accordance with claim 12, further comprising verifying completeocclusion of the neck by injection of contrast agent through multipleside holes just proximal to the balloon and simultaneously appliedsuction through the one-way valve at the distal end of the catheteruntil no inflow of the contrast is demonstrated together withdeformation of the aneurysm with suction, indicating that the aneurysmneck is completely closed.
 14. A method in accordance with claim 13,further comprising continuing suction with the aneurysm neck completelyclosed to almost completely collapse the aneurysm by creating a vacuumwithin the aneurysm.
 15. A method in accordance with claim 12, furthercomprising measuring transverse and longitudinal dimensions of theaneurysm.
 16. A method in accordance with claim 13, further comprisingmaintaining vacuum within the aneurysm with continuous suction andadhering the aneurysm wall to sides of the clip.
 17. A method inaccordance with claim 16, further comprising repeating the pulling stepuntil successive segments fold and complete collapse of the aneurysm isbe achieved.
 18. A method in accordance with claim 12, furthercomprising perform a road-mapping arteriogram with measurement of thethree dimensional size of the aneurysm and its neck.
 19. A method inaccordance with claim 12, further comprising accessing the aneurysm neckusing a steerable catheter.
 20. A method in accordance with claim 19,further comprising locking the distal end of the catheter in a positionperpendicular to the center of the neck transverse axis.
 21. A method inaccordance with claim 12, further comprising inflating a balloon mountedon the distal end of a catheter with a diluted contrast to thepreviously measured size of the neck.
 22. A method in accordance withclaim 12, further comprising: pulling a stretching bar to telescope avery distal segment of the stretching bar into the next proximal segmentof the stretching bar.